CA2523079A1 - Solid pharmaceutical preparation containing levothyroxine and/or liothyronine salts - Google Patents

Solid pharmaceutical preparation containing levothyroxine and/or liothyronine salts Download PDF

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Publication number
CA2523079A1
CA2523079A1 CA002523079A CA2523079A CA2523079A1 CA 2523079 A1 CA2523079 A1 CA 2523079A1 CA 002523079 A CA002523079 A CA 002523079A CA 2523079 A CA2523079 A CA 2523079A CA 2523079 A1 CA2523079 A1 CA 2523079A1
Authority
CA
Canada
Prior art keywords
pharmaceutical preparation
carrier
water
preparation according
edta
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002523079A
Other languages
French (fr)
Other versions
CA2523079C (en
Inventor
Walter Burghart
Kurt Burghart
Johannes Raneburger
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Globopharm Pharmazeutische Produktions und Handelsgesellschaft mbH
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
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Application filed by Individual filed Critical Individual
Publication of CA2523079A1 publication Critical patent/CA2523079A1/en
Application granted granted Critical
Publication of CA2523079C publication Critical patent/CA2523079C/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4

Abstract

The invention relates to a solid pharmaceutical preparation containing water-soluble salts of Levothyroxine and/or Liothyronine as active agent, wherein water activity of the pharmaceutical preparation measured at room temperature is set to values below 0.4, preferably 0.1 to 0.3.

Claims (15)

1. A solid pharmaceutical preparation containing water-soluble salts of levothyroxine and/or liothyronine as active ingredients, characterized in that the water activity of said pharmaceutical preparation is adjusted to values of below 0.4 and above 0.1, measured at room temperature.
2. A pharmaceutical preparation according to claim 1, characterized in that the water activity of said pharmaceutical preparation is adjusted to values ranging from 0.1 to 0.3, measured at room temperature.
3. A pharmaceutical preparation according to claim 1 or 2, characterized in that the active ingredient from a methanolic/ethanolic solution is homogenously applied on a carrier optionally mixed with starch, guar or granulation aids.
4. A pharmaceutical preparation according to claim 1, 2 or 3, characterized in that the active ingredient is applied on a water-soluble carrier.
5. A pharmaceutical preparation according to any one of claims 1 to 4, characterized in that mannitol is used as a water-soluble carrier.
6. A pharmaceutical preparation according to any one of claims 1 to 5, characterized in that the carrier is treated with an amount of EDTA-Na substantially corresponding to the Ca++-content of the carrier, and optionally citric acid.
7. A pharmaceutical preparation according to any one of claims 1 to 6, characterized in that the preparation is present in the form of tablets and confectioned with non-hygroscopic adjuvants and/or in a package with only little or no water-vapor permeability.
8. A method for producing a pharmaceutical preparation according to any one of claims 1 to 7, characterized in that a carrier of mannitol is coated or sprayed with an alcoholic solution of the active ingredient, whereupon the alcoholic solvent is evaporated until a water factor of below 0.4 and, in particular, below 0.3 and above 0.1 has been reached, and tableting is subsequently effected.
9. A method according to claim 8, characterized in that water or an aqueous solution containing EDTA-Na and/or citric acid is applied prior to evaporating said solvent.
10. A method according to claim 8 or 9, characterized in that directly tabletable mannitol and, in particular, Pearlitol is used as a carrier.
11. A method according to claim 8, 9 or 10, characterized in that hydrophobic adjuvants such as, e.g., magnesium stearate are used as tableting aids and, in particular, lubricants.
12. A method according to any one of claims 8 to 11, characterized in that the carrier, prior to being coated or sprayed with the active ingredient solution is supplemented with EDTA-Na and optionally citric acid, in an amount sufficient for complexing bivalent ions of the carrier and other sources such as solvents.
13. A method according to any one of claims 8 to 12, characterized in that the carrier is wetted with methanol prior to being supplemented with EDTA-Na and optionally citric acid.
14 14. A method according to any one of claims 8 to 13, characterized in that the composition is kept free of hygroscopic adjuvants.
15. A method according to any one of claims 8 to 13, characterized in that the composition contains hygroscopic adjuvants, yet is packed in a water-vapor-tight package.
CA2523079A 2003-05-02 2004-05-03 Solid pharmaceutical preparation containing levothyroxine and/or liothyronine salts Active CA2523079C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ATA667/2003 2003-05-02
AT6672003 2003-05-02
PCT/AT2004/000150 WO2004096177A1 (en) 2003-05-02 2004-05-03 Solid pharmaceutical preparation containing levothyroxine and/or liothyronine salts

Publications (2)

Publication Number Publication Date
CA2523079A1 true CA2523079A1 (en) 2004-11-11
CA2523079C CA2523079C (en) 2012-08-14

Family

ID=33314944

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2523079A Active CA2523079C (en) 2003-05-02 2004-05-03 Solid pharmaceutical preparation containing levothyroxine and/or liothyronine salts

Country Status (13)

Country Link
EP (1) EP1622587B1 (en)
JP (1) JP5414146B2 (en)
AT (1) ATE465718T1 (en)
AU (1) AU2004234176B2 (en)
BR (1) BRPI0410021A (en)
CA (1) CA2523079C (en)
DE (1) DE502004011103D1 (en)
DK (1) DK1622587T3 (en)
ES (1) ES2344294T3 (en)
PT (1) PT1622587E (en)
RU (1) RU2361573C2 (en)
WO (1) WO2004096177A1 (en)
ZA (1) ZA200509026B (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9012438B2 (en) 2002-11-13 2015-04-21 Aldo Pinchera 3,5,3′ -triiodothronine sulfate as thyromimetic agent and pharmaceutical formulations thereof
US9890116B2 (en) 2002-11-13 2018-02-13 Bracco Imaging S.P.A. Process for the preparation of a sulfated derivative of 3,5-diiodo-O-[3-iodophenyl]-L-tyrosine

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2897267A1 (en) * 2006-02-16 2007-08-17 Flamel Technologies Sa MULTIMICROPARTICULAR PHARMACEUTICAL FORMS FOR PER OS ADMINISTRATION
RU2485949C2 (en) * 2007-04-11 2013-06-27 Фармасьютикал Продакшнс Инк Tablet of melatonin and method for preparing and using
LT2885005T (en) * 2012-08-20 2017-12-27 Merck Patent Gmbh Solid pharmaceutical preparation containing levothyroxine

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5225204A (en) * 1991-11-05 1993-07-06 Chen Jivn Ren Stable dosage of levothyroxine sodium and process of production
DE19541128C2 (en) * 1995-10-27 1997-11-27 Henning Berlin Gmbh & Co Stabilized thyroid hormone-containing medicines
US5635209A (en) * 1995-10-31 1997-06-03 Vintage Pharmaceuticals, Inc. Stabilized composition of levothyroxine sodium medication and method for its production
MXPA98003802A (en) * 1995-11-14 2005-04-29 Abbott Gmbh & Co Kg Stabilized thyroid hormone preparations and methods of making same.
JP2001114712A (en) * 1996-04-16 2001-04-24 Takeda Chem Ind Ltd D-mannitol and method for producing the same
DE19653410A1 (en) * 1996-12-20 1998-06-25 Basf Ag Use of carotenoid solubilisates for coloring food and pharmaceutical preparations
AU1337999A (en) * 1997-11-17 1999-06-07 Gist-Brocades B.V. Granules comprising clavulanate and one or more excipients
JP3274416B2 (en) * 1998-05-29 2002-04-15 佐藤製薬株式会社 Orally disintegrating granular preparation
FR2781793B1 (en) 1998-08-03 2001-07-20 Prographarm Lab PROCESS FOR PRODUCING COATED GABAPENTINE GRANULES
JP2000060535A (en) * 1998-08-21 2000-02-29 Kyowa Hakko Kogyo Co Ltd Preservation of microorganismal cell
JP3491887B2 (en) * 1999-04-28 2004-01-26 フロイント産業株式会社 Method for producing aggregates of sugar alcohol granules
GB9919487D0 (en) * 1999-08-17 1999-10-20 Nestle Sa Moulded onfectionery product comprising vegetables
JP4677084B2 (en) * 1999-09-30 2011-04-27 武田薬品工業株式会社 Solid preparation containing bromhexine hydrochloride
US6399101B1 (en) * 2000-03-30 2002-06-04 Mova Pharmaceutical Corp. Stable thyroid hormone preparations and method of making same
TWI307339B (en) * 2000-06-30 2009-03-11 Glaxo Group Ltd Quinazoline ditosylate salt comprounds
ES2174734B1 (en) * 2000-11-03 2003-10-01 Belmac S A Lab NEW GALENIC FORMULATION OF DISPERSABLE AND SOLUBLE PARACETAMOL, PROCEDURE FOR PREPARATION AND APPLICATIONS.
EP1365745A2 (en) * 2001-02-15 2003-12-03 King Pharmaceuticals, Inc. Stabilized pharmaceutical and thyroid hormone compositions and method of preparation
JP4291962B2 (en) * 2001-03-27 2009-07-08 あすか製薬株式会社 Stable thyroid hormone-containing solid pharmaceutical composition
EP1461307A2 (en) 2002-01-07 2004-09-29 Abbott GmbH & Co. KG Crystallization of amino acids using ultrasonic agitation

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9012438B2 (en) 2002-11-13 2015-04-21 Aldo Pinchera 3,5,3′ -triiodothronine sulfate as thyromimetic agent and pharmaceutical formulations thereof
US9044441B2 (en) 2002-11-13 2015-06-02 Bracco S.P.A. 3,5,3′-triiodothyronine sulfate as thyromimetic agent and pharmaceutical formulations thereof
US9468619B2 (en) 2002-11-13 2016-10-18 Bracco S.P.A. 3,5,3′-triiodothyronine sulfate as thyromimetic agent and pharmaceutical formulations thereof
US9890116B2 (en) 2002-11-13 2018-02-13 Bracco Imaging S.P.A. Process for the preparation of a sulfated derivative of 3,5-diiodo-O-[3-iodophenyl]-L-tyrosine
US10238615B2 (en) 2002-11-13 2019-03-26 Bracco S.P.A. 3,5,3′-triiodothyronine sulfate as thyromimetic agent and pharmaceutical formulations thereof
US10457635B2 (en) 2011-04-08 2019-10-29 Bracco Imaging S.P.A. Process for the preparation of a sulfated derivative of 3,5-diiodo-o-[3-iodophenyl]-l-tyrosine

Also Published As

Publication number Publication date
ATE465718T1 (en) 2010-05-15
DK1622587T3 (en) 2010-08-23
AU2004234176B2 (en) 2010-05-13
CA2523079C (en) 2012-08-14
EP1622587B1 (en) 2010-04-28
JP2006525234A (en) 2006-11-09
RU2005137577A (en) 2006-05-10
DE502004011103D1 (en) 2010-06-10
AU2004234176A1 (en) 2004-11-11
ES2344294T3 (en) 2010-08-24
JP5414146B2 (en) 2014-02-12
RU2361573C2 (en) 2009-07-20
WO2004096177A1 (en) 2004-11-11
ZA200509026B (en) 2007-03-28
EP1622587A1 (en) 2006-02-08
BRPI0410021A (en) 2006-04-25
PT1622587E (en) 2010-07-07

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